IT Systems Compliance
Believe it or not, Information Technology (IT) today is not only essential, but has even become a critical cornerstone on which your business is built. To name but a few: network security, data protection, system validation, change management, training, procedures and IT governance framework, are all aspects of the drug development process which must be carefully assessed, addressed and managed to satisfy regulatory & legal requirements. Failing to understand this could lead to non-compliance.
idCO knows exactly how to tackle this challenge, where to start, what is needed and who needs to be involved. Setting and reaching agreed, comprehensive and specific objectives together can help develop and/or improve your information management systems' effectiveness, efficiency, confidentiality, integrity, availability, compliance and reliability. Our area of expertise can be grouped into four fields of activity:
Planning and Organization
- Assess/define the IT processes, organization and relationships
- Manage Quality
- Assess and manage IT risks
- Manage Projects
Acquisition and Implementation
- Identify automated solutions
- System Validation
- Implement change management processes
Delivery and Support
- Define and manage service levels
- Manage third party services (Vendor Audits)
- Educate and train users
Monitoring and Evaluation
- Monitor and evaluate IT performance
- Monitor and evaluate internal control